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Job ID :
54744BR
Location :
US - California - South San Francisco
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

The Process Development Manager is part of Operations and will be responsible for developing and/or improving manufacturing processes. The incumbent will provide technical leadership to identify, evaluate, procure, install and qualify new equipment and systems; support and troubleshoot existing equipment for various processes. The role is also responsible for effective collaboration with Manufacturing, Quality, R&D, Facilities and various vendors.

In partnership with R&D and Operations, this role will develop appropriate analytics for in-process testing Methods Development – Converting from R&D scale to Manufacturing (batch) scale under proper statistics. Working as an interface between R&D and Ops, the Process Development Manager will write the appropriate manufacturing documents and test the impact of different source/supplier materials at batch scale on product/manufacturing robustness.

Responsibilities:

  • Create and/or review/approve documentation to support new and improved manufacturing processes. Write and perform process validations (IQ, OQ, PQ, PPQ) and validate methods for inspection for verification and process controls
  • Oversee and manage the Operations staff, including hiring, performance management, training and professional development
  • Interface directly with R&D and production to understand new requirements for manufacturing processes
  • Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans
  • Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on commercial products
  • Apply technical knowledge to innovate, design, and develop processes and procedures and to incorporation automation
  • Execute the functional deliverables associated with the CAPA, Strategic Initiative, and Quality Systems
  • Plan, organize, and conduct all aspects of technical reviews
  • Ensure proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, FMEA’s, etc.)
  • Write and review validation protocols and report applicable to new processes
  • May serve as a core team member or extended team member on new product projects
  • Critically analyze complex data, interpret and integrate experiment results with project and Department objectives
  • Determine project directives based on data analysis
  • Maintain complete and thorough documentation in accordance with required US and international standards (e.g., ISO compliance, GLP/GMP/QSR requirements, etc.) for assigned staff
  • Prepare technical reports, product summaries, protocols, and quantitative analyses
  • Developing appropriate analytics for in-process testing
Minimum Qualifications:
  • Bachelor’s degree in the Life Sciences or related field
  • 7 years of industry experience, preferably in a commercial environment
  • Previous manufacturing management experience
  • Proven supervisory or management experience to lead assigned process development staff
  • Experience in multi-faceted research planning and design
  • Knowledge of safety, environmental and other regulatory requirements
  • Demonstrated proficiency in data analysis, research design and the evaluation of new techniques and procedures for manufacturing reagents, systems, products or technologies
  • Excellent time management skills and ability to work independently required
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities
  • Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner
Preferred Qualifications:
  • Knowledgeable with Hamilton Robotics systems or similar platform
  • Knowledgeable with PCR
  • Solid technical writing skills

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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